← FDA DRUG APPROVALS

FDA NDA · NDA216318

AZMIRO

testosterone cypionate

Sponsor: AZURITY

APPLICATION
NDA216318
TYPE
NDA
ORIGINAL APPROVAL
2022-06-02
LATEST ACTION
2025-07-11
ROUTE
INTRAMUSCULAR
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

AZMIRO · ReferencePrescription
TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) · SOLUTION · INTRAMUSCULAR

Approval history

2025-07-11Labeling · Supplement 5 · standard — Label ↗AP
2024-12-18Labeling · Supplement 3 · standard — Letter ↗AP
2024-02-01Labeling · Supplement 2 · standard — Letter ↗AP
2022-06-02Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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